Closed male luer device for minimizing leakage during connection and disconnection

ABSTRACT

A medical connector for minimizing leakage of fluids during connection and disconnection is described. The medical connector includes a body having an inlet port, at least one outlet port adjacent to a male luer portion of the body, and a fluid path between the inlet port and the at least one outlet ports. A retractable seal adjacent to the male luer portion of the body and blocks the outlet ports of the body when the male luer portion of the medical connect is in a disconnected state. The retractable seal is positioned on the body such that it is moved away from the outlet ports upon insertion of the male luer portion of the medical connector into a medical access device thereby unblocking the outlet ports and creating a fluid path through the medical connector.

This application is a continuation of U.S. application Ser. No.12/204,962, filed Sep. 5, 2008, entitled, “CLOSED MALE LUER DEVICE FORMINIMIZING LEAKAGE DURING CONNECTION AND DISCONNECTION,” U.S. Pat. No.8,888,758, the disclosure of which is incorporated herein by referencein its entirety.

TECHNICAL FIELD Background of the Invention

Medical connections are widely used in fluid delivery systems such asthose used in connection with intravenous fluid lines, blood access,hemodialysis, peritoneal dialysis, enteral feeding, drug vial access,etc. Many prior art aseptic medical connections has been to puncture anelastomeric diaphragm or septum, which has one side in contact with thefluid, with a sharpened hollow hypodermic needle. The use of suchhypodermic needles has been gradually decreasing as a result of bothsafety and cost considerations associated with infectious diseaseacquired from needle sticks. These connectors have been replaced withluer activated connectors which don't require hypodermic needles, butinstead use an activator such as a luer on the end of a syringe or IVline to create a fluid path though a valve in a connector. The removalof the connector causes the valve to close when the line isdisconnected. Such a system is described in U.S. Pat. No. 5,569,235 toRoss et al.

Typical connectors and valves of this type, such as described by Ross,have many attributes that are not ideal in medical applications fordelivery of fluids that could be harmful if contacted by the health careprovider or the patient other than through the patient's intravenous(“IV”) connection. Oncology drugs such as chemotherapy are examples offluids that while beneficial to the patient as part of a treatmentregimen could be extremely harmful to the health care provider if thechemotherapy drug were to come into contact with the skin of the healthcare provider or patient.

Traditional medical connectors require the health care provider toexercise great care on connection or disconnection due to the likelihoodof the drug remaining inside the connector or dripping, particularly ondisconnection when the connectors are primed with fluid. Some femaleconnectors are designed to push fluid in the throat of the connector tothe surface during disconnection. While this is desirable for asepticconnectors to provide a swabbable surface, it can result in fluid dripsfrom the device on disconnection. Other connectors use a membrane with aseptum that can also allow fluids to escape the connector.

What is needed is a connector for medical fluids that has standardizedconnections for use with existing medical connectors and also minimizesor eliminates drips on connection or disconnection

BRIEF SUMMARY OF THE INVENTION

Embodiments of the concepts described herein describe a medicalconnector and method for minimizing fluid leakage, the medical connectorand method including a body having an inlet port, at least one outletport adjacent to a male luer portion of the body, and a fluid pathbetween the inlet port and the at least one outlet ports. A retractableseal is adjacent to the male luer portion of the body to block theoutlet ports of the body when the male luer portion of the medicalconnect is in a disconnected state. The retractable seal is positionedon the body such that it is moved away from the outlet ports uponinsertion of the male luer portion of the medical connector into amedical access device thereby unblocking the outlet ports and creating afluid path through the medical connector.

In other embodiments a medical connector is described for connecting toa medical access device, the connector including a body having an inletport, at least one outlet port adjacent to a male luer portion of thebody, and a fluid path between the inlet port and the at least oneoutlet ports, and a flexible sleeve fitted over the male luer portion ofthe body and fixed to the body at an end distal from the outlet ports.The flexible sleeve includes a seal ring proximal to the outlet ports ofthe body and is operable to seal the outlet ports when the flexiblesleeve is in an extended state. The flexible sleeve is positioned to becompressed when the male luer portion of the body is inserted into themedical access device. The compression causes the seal ring to be movedaway from the outlet ports along the male luer portion of the bodythereby unsealing the outlet ports and creating a fluid path through theconnector.

In another embodiment a method of connecting a connector and an accessdevice to create fluid path for medical fluids is described. The methodincludes inserting a male luer portion of the connector into a femaleluer portion of the access device and causing a seal blocking outletports in the male luer portion of the connector to be retracted from theoutlet ports. The method further includes creating a fluid path throughthe connectors when the male luer portion of the connector has beeninserted sufficiently into the access device to create a fluid path fromthe connector through the outlet ports into the access device, andcausing the seal to reseal the outlet ports upon removal of the maleluer portion of the connector from the female luer portion of the accessdevice.

The foregoing has outlined rather broadly the features and technicaladvantages of the present invention in order that the detaileddescription of the invention that follows may be better understood.Additional features and advantages of the invention will be describedhereinafter which form the subject of the claims of the invention. Itshould be appreciated by those skilled in the art that the conceptionand specific embodiment disclosed may be readily utilized as a basis formodifying or designing other structures for carrying out the samepurposes of the present invention. It should also be realized by thoseskilled in the art that such equivalent constructions do not depart fromthe spirit and scope of the invention as set forth in the appendedclaims. The novel features which are believed to be characteristic ofthe invention, both as to its organization and method of operation,together with further objects and advantages will be better understoodfrom the following description when considered in connection with theaccompanying figures. It is to be expressly understood, however, thateach of the figures is provided for the purpose of illustration anddescription only and is not intended as a definition of the limits ofthe present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention, reference isnow made to the following descriptions taken in conjunction with theaccompanying drawing, in which:

FIG. 1 is a perspective view of an embodiment of a male luer medicalconnector for fluid delivery according to the concepts described herein;

FIG. 2 is a sectional view of the male luer medical connector shown inFIG. 1;

FIGS. 3A-3C are perspective views of embodiments of the components ofthe male luer medical connector shown in FIG. 1; and

FIGS. 4A and 4B are sectional views of an embodiment of a male luermedical connector in accordance with the concepts shown herein and adeformable valve plug type medical connector in a disconnected state anda connected state respectively.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to FIG. 1, an embodiment of a medical connector 100 inaccordance with the concepts described herein is shown. Medicalconnector 100 operates as a spin lock luer having a body 101 and a spinlock portion 102. The male luer body is ISO 594-2 compliant andinterfaces with standard needless access devices. Medical connector 100differs from traditional spin lock luer by the inclusion of aretractable elastic sleeve 103 over male luer portion 105 at the distalend of medical connector 100. The proximal end of medical connector 100includes an inlet port 104 that can be connected to fluid deliverysources or devices such as IV fluid bags, pumps or the like.

As with traditional needleless medical connectors, male luer portion 105of medical connector 100 is inserted into the female luer of anotherneedleless access device to create a fluid path between a fluid deliverymechanism and a patient. In order to avoid drips and leakage of medicalfluids that may be harmful to health care providers or patients, medicalconnector 100 is designed to minimize or eliminate fluid drips orleakage upon connection of medical connector 100 with another accessdevice, or particularly upon disconnection from another access devicewith both devices are primed with fluid.

Referring now to FIG. 2, the medical connector from FIG. 1 is shown in asectional view. As described, medical connector 200 includes body 201.Body 201 has an inlet port 204 adjacent to a threads 211 which allowconnector 201 to be securely attached to other access devices. Inletconnection 210, which is shown here as a female luer connector thataccepts the male luer of another needleless access devices and allowsfluids to pass into fluid path 212. While connector 200 is shown ashaving a female luer type connector, any type of inlet port could beused, such as a bond pocket or other connector, while remaining withinthe scope of the concepts described herein. Fluid path 212 communicateswith outlet ports 206 in male luer portion 205 of connector 200. Unlikeother similar medical connectors in which the fluid path is directly outthe end of the male luer, outlet ports 206 are channels in the sides ofmale luer portion 205 of body 201 and the tip of male luer portion 205is closed. In embodiments of the medical connector according to theconcepts described herein the tip of male luer portion 205 may include asqueegee tip 207, the function of which will be described with referenceto FIG. 4. Spin lock portion 202 surrounds the distal end of body 201and includes inner chamber 209 which has threads for connecting medicalconnector 200 to other access devices.

Also surrounding male luer portion 205 of body 201 inside chamber 209 ofspin lock portion 202 is flexible sleeve 203. Flexible sleeve 203includes seal ring 219 at its distal end which operates to block outletports 206 when flexible sleeve 203 is in its extended position as shownin FIG. 2. As will be discussed, flexible sleeve 203 can be pushed backinto chamber 209 unblocking outlet ports 206 and completing the fluidpath 212 through connector 200. In embodiments of flexible sleeve 203,sleeve portion 208 can be formed in an accordion shape to allow sleeveportion 208 to bunch together as seal ring 219 is pushed into chamber209 by the engagement of connector 200 to another access device.

Referring now to FIGS. 3A, 3B and 3C embodiments of the body, flexiblesleeve and spin lock portion, respectively, of a medical connectoraccording to the concepts describe herein are shown. FIG. 3A shows anembodiment of body 301. As described, body 301 includes inlet port 304having connection mechanism 310, outlet ports 306, fluid path 312 andmale luer portion 305. Threads 311 or other connection mechanisms can beplaced at the proximal end of body 301 adjacent to inlet port 304. Grips317 are used to facilitate manipulation of body 301 by health carepersonnel. Plate 313 works with flange 318 and groove 314 to hold spinlock portion 302 while allowing it to spin with respect to body 301. Aflange in spin lock portion 302 fits snaps into groove 314 and spin lockportion is held in place by plate 313 and flange 318.

Similarly, flange 318, groove 315 and flange 316 are used to holdflexible sleeve 303 in position relative to body 301. Another flangeinside end 321 of flexible sleeve 303 fits into groove 315 and is heldin place by flanges 318 and 315, thereby holding flexible sleeve 303 inplace. While flange and groove arrangements have been shown to attachspin lock portion 302 and flexible sleeve 303 to body 301, one skilledin the art would recognize that any number of arrangements could beemployed to connect the various parts while still being within the scopeof the concepts described herein. For example, adhesives, locking hubs,friction fittings or other connection mechanisms could be used toassemble the individual elements into a finished medical connector. Body301 is preferably formed from polycarbonate plastic but could be formedfrom any number of materials appropriate for medical connectors.

An embodiment of flexible sleeve 303 is shown in FIG. 3B. Flexiblesleeve 303 includes end 321 which provides the attachment to body 301,sleeve portion 308 and seal ring 319. Inner surface 320 of seal ring 319blocks outlet ports 306 of body 301 when flexible sleeve 303 is in itsextended position. Seal ring 319 of flexible sleeve 303 may be pushedtoward end 321 as will be described with reference to FIG. 4B causingflexible sleeve 303 to shorten or compress along sleeve portion 308.Sleeve portion 308 may be formed in an accordion shape to allow sleeveportion 308 to bunch together or fold up as flexible sleeve 303 iscompressed, or sleeve portion 308 may be merely formed of a compressiblematerial, or otherwise formed or shaped to allow compression andshortening of sleeve portion 308.

As flexible sleeve 303 is shortened, inner surface 320 of seal ring 319is moved away from outlet ports 306 causing them to be unblock andthereby opening a flow path through body 301. Since embodiments of maleluer portion 305 of body 301 may be tapered, the inner diameter offlexible may need to be tapered as well to ensure that inner surface 320is tight enough against outlet ports 306 to prevent fluid from escaping.Because of this taper, seal ring 319 and sleeve portion 308 should beable to expand as flexible sleeve 303 is compressed. This expansion orstretching of flexible sleeve 303 has the benefit of aiding in thereturn of flexible sleeve 303 to the extended position when thecompression force to seal ring 309 is removed. Flexible sleeve 303 ispreferably made from medical grade silicon, but can be made from anymaterial that has the characteristics described with respect to flexiblesleeve 303.

Spin lock portion 302 is designed to snap over body 301 as describedabove. Spin lock portion includes chamber 309 which holds male luerportion 305 of body 301 and flexible sleeve 303. Threads 323 on theinner surface of chamber 309 allow for secure connection to otherthreaded medical access devices. Grip rails 322 allow spin lock portion302 to be firmly gripped by health care personnel during twistingmotions required to thread or unthread spin lock portion 302 onto or offof another medical access device.

Referring now to FIGS. 4A and 4B, an embodiment of a medical connector400 is shown in relation to another medical access device 450 toillustrate the operation of connector 400. FIG. 4A shows connector 400disengaged from medical access device 450 while FIG. 4B shows connector400 engaged with medical access device 450, creating a fluid paththerethrough. Reference will be made to FIGS. 4A and 4B interchangeablyas the operation of connector 400 is described.

Connector 400 includes body 401 having an inlet connection mechanism410, spin lock portion 402 and flexible sleeve 403 as described above.Spin lock portion 402 is secured to body 401 by fitting spin lock flange424 into groove 414 on body 401. Flange 418 and plate 413 hold spin lockportion 402 in place while allowing spin lock portion 402 to spin freelyin relation to body 401. Flexible sleeve 403 has its distal end held inplace on body 401 by flange 425 engaging with groove 415 and held inplace by flange 416 on body 401. As described, seal ring 419 of flexiblesleeve is positioned to block outlet ports 406 in male luer 405 ofconnector 400.

As can be seen in FIG. 4A, when connector 400 is aligned with medicalaccess device 401, surface 426 of seal ring 419 aligns to engage surface455 of the female luer portion 457 of device 450. Further, mail luerportion 405 of connector 400 aligns with surface 454 of valve plug 453.FIG. 4B show connector 400 engaged with device 450. In the engagedstate, contact between surface 426 of flexible sleeve 403 and surface455 of device 450 causes flexible sleeve to be compressed into chamber409 formed by spin lock portion 402.

In the embodiment of flexible sleeve 403 shown, sleeve portion 408 foldsalong accordion bends, though other mechanisms to control thecompression are well within the scope of the concepts described herein.As flexible sleeve 403 is compressed, it no longer blocks outlet valves406. However, outlet valves 406 are then blocked by the inner surface ofthroat of female luer portion 457 of device 450.

As male luer portion 405 of connector 400 continues to be inserted intodevice 450, valve plug 453 compresses into device 450 and the tip ofmale luer portion 405 reaches chamber 456 where outlet ports 406 are nolonger blocked and flow path 412 through connector 400 and medicalaccess device 450 is completed. Connector 400 and device 450 may besecurely attached using threads on spin lock portion 402 of connector400 and threads on female luer portion 457 of device 450.

Upon disconnection, removing connector 400 from device 450 causes outletports 406 to again be blocked by the inner surface of the throat offemale luer portion 457. This interrupts the fluid path 412 and stopsthe flow of fluid through connector 400. As connector 400 is disengaged,flexible sleeve 403 extends along male luer portion 405 and as outletports 406 are removed from device 450, they are immediately blocked byseal ring 419. A squeegee tip 207 from FIG. 2 can be used to draw excessfluid from the throat of device 450 into the space between flexiblesleeve 403 and male luer portion 405 as connector 400 is withdrawn. Evenwithout the squeegee tip, the only fluid that should be released duringdisconnection would be that fluid trapped in the throat of device 450 asplug 453 extends to seal device 450.

While access device 450 is shown as having a valve plug arrangement,connector 400 will work with any standard female luer of a medicalaccess device including bellows type plugs, devices with septums, orother configurations designed to accept standardized male luerconnectors.

Although the present invention and its advantages have been described indetail, it should be understood that various changes, substitutions andalterations can be made herein without departing from the spirit andscope of the invention as defined by the appended claims. Moreover, thescope of the present application is not intended to be limited to theparticular embodiments of the process, machine, manufacture, compositionof matter, means, methods and steps described in the specification. Asone of ordinary skill in the art will readily appreciate from thedisclosure of the present invention, processes, machines, manufacture,compositions of matter, means, methods, or steps, presently existing orlater to be developed that perform substantially the same function orachieve substantially the same result as the corresponding embodimentsdescribed herein may be utilized according to the present invention.Accordingly, the appended claims are intended to include within theirscope such processes, machines, manufacture, compositions of matter,means, methods, or steps.

What is claimed is:
 1. A medical connector comprising: a body having aninlet port, at least one outlet port in a sidewall of a male luerportion of the body, and a fluid path between the inlet port and the atleast one outlet port; a flexible sleeve surrounding the male luerportion of the body and configured to compress along the male luerportion upon insertion of the male luer portion of the medical connectorinto a medical access device, wherein the at least one outlet port isblocked by the flexible sleeve when the male luer portion of the medicalconnector is in a disconnected state, and the at least one outlet portis unblocked when the flexible sleeve compresses along the male luerportion; and a squeegee tip fixed to a lumen through a distal end of themale luer portion proximal to the at least one outlet port, wherein (i)the squeegee tip extends through the lumen and a squeegee portion of thesqueegee tip extends distally of the distal end of the male luerportion, and (ii) an outer surface of the squeegee portion is configuredto draw fluid from an inner surface of the medical access device duringretraction of the male luer portion from the medical access device, andwherein the squeegee tip remains fixed to the end of the male luerportion after retraction of the sleeve.
 2. The medical connector ofclaim 1 further comprising a spin lock attached to the body, the spinlock including threads for attachment to the medical access device. 3.The medical connector of claim 1, wherein the flexible sleeve is fixedto an end of the male luer portion of the body proximally of the atleast one outlet port.
 4. The medical connector of claim 1, wherein thesqueegee tip is configured to remove excess fluid from the medicalaccess device.
 5. The medical connector of claim 4, wherein the squeegeetip is configured to trap the excess fluid between the flexible sleeveand the male luer portion of the body.
 6. The medical connector of claim1, wherein a retractable seal ring is coupled to the flexible sleeveproximal to the at least one outlet port such that the fluid path isblocked by the seal ring when the male luer portion of the medicalconnector is in a disconnected state.
 7. A medical connector forconnecting to a medical access device, the connector comprising: a bodyhaving an inlet port, at least one outlet port in a sidewall of a maleluer portion of the body, and a fluid path between the inlet port andthe at least one outlet port; a flexible sleeve fitted over thesidewall, the flexible sleeve blocking the at least one outlet port ofthe body when the male luer portion of the medical connector is in anextended state, wherein the flexible sleeve compresses along the maleluer portion upon insertion of the male luer portion of the medicalconnector into a medical access device thereby unblocking the at leastone outlet port and creating a fluid path through the medical connector;a squeegee tip extending through a lumen through a distal end of themale luer portion, the squeegee tip comprising a squeegee portionextending distally of the distal end of the male luer portion, whereinan outer surface of the squeegee is configured to draw fluid from aninner surface of the medical access device during retraction of the maleluer portion from the medical access device; and a lock attached to thebody, the lock including threads for attachment to the medical accessdevice.
 8. The medical connector of claim 7, wherein the flexible sleeveincludes a seal ring proximal to the at least one outlet port of thebody and operable to seal the at least one outlet port when the flexiblesleeve is in an extended state, and wherein the seal ring is moved awayfrom the at least one outlet port along the male luer portion of thebody thereby unsealing the at least one outlet port and creating a fluidpath through the connector when the flexible sleeve is compressed alongthe male luer portion.
 9. The medical connector of claim 7, wherein asqueegee tip is affixed to an end of the male luer portion proximal tothe at least one outlet port.
 10. The medical connector of claim 9,wherein the squeegee tip is configured to remove excess fluid from themedical access device and to trap the excess fluid between the flexiblesleeve and the male luer portion of the body.
 11. A method of connectinga connector and an access device to create a fluid path for medicalfluids, the method comprising: inserting a male luer portion of theconnector into a female luer portion of the access device, wherein theconnector includes a squeegee tip fixed to an end of the male luerportion proximal to at least one outlet port in a sidewall of the maleluer portion, wherein the squeegee tip extends through a lumen throughthe distal end of the male luer, and a squeegee portion of the squeegeetip extends distally of the distal end of the male luer, the at least onoutlet port being blocked by a flexible sleeve comprising a sealportion; compressing the flexible sleeve surrounding the sidewall,thereby unblocking the at least one outlet port; creating a fluid paththrough the connectors when the male luer portion of the connector hasbeen inserted sufficiently into the access device to create a fluid pathfrom the connector through the at least one outlet port into the accessdevice; drawing excess fluid from an inner surface of the female luerportion with an outer surface of the squeegee portion during retractionof the male luer portion from the female luer portion; and sealing theat least one outlet port upon removal of the male luer portion of theconnector from the female luer portion of the access device by expandingthe flexible sleeve such that a sealing portion of the flexible sleeveblocks the at least on outlet port.
 12. The method of claim 11 whereinthe seal portion is (i) part of the flexible sleeve that surrounds themale luer portion of the body, and (ii) fixed to an end of the male luerportion of the body proximally of the at least one outlet port.
 13. Themethod of claim 12 wherein unblocking the at least one outlet portcomprises compressing the flexible sleeve along the male luer portionupon insertion into the medical access device.
 14. The method of claim11 further comprising removing excess fluid from the medical accessdevice by trapping excess fluid with the squeegee tip in the medicalconnector between the outer surface of the sidewall, the squeegee tip,and an inner surface of the flexible sleeve.
 15. The method of claim 14wherein the flexible sleeve is fixed to an end of the male luer portiondistally of the at least one outlet port and the excess fluid is trappedbetween the flexible sleeve and the male luer portion.